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The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.
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In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.
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A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings. conditions: Parenting conditions: Parent-Child Relations conditions: Substance Use Disorders conditions: Stress conditions: Depression conditions: Anxiety conditions: Parenting Self-efficacy conditions: Pediatrics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 36 type: ESTIMATED name: Family Check-Up Online measure: change from baseline in parenting skills measure: change from baseline in parenting efficacy measure: change from baseline in parent executive functioning measure: change from baseline in child social-emotional behavior measure: change from baseline in family conflict measure: change from baseline in parental substance use measure: change from baseline in parental depression measure: change from baseline in parental anxiety measure: change from baseline in parental stress measure: change from baseline in parental impact of negative life events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prevention Science Institute, University of Oregon status: RECRUITING city: Eugene state: Oregon zip: 97403 country: United States name: Katherine Hails, PhD role: CONTACT phone: 610-457-8627 email: khails@uoregon.edu name: Elizabeth Stormshak, PhD role: CONTACT phone: 541-912-3792 email: bstorm@uoregon.edu name: Katherine Hails, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.05207 lon: -123.08675 hasResults: False
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<|newrecord|> nctId: NCT06273215 id: DCTC-IIR202217 briefTitle: Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients overallStatus: RECRUITING date: 2023-03-05 date: 2025-12-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Peking University Third Hospital class: OTHER briefSummary: 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM). conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ESTIMATED name: The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach. measure: Pharmacokinetics of study drug measure: Concentration of endogenous markers of CYP3A and OATP measure: Genotype of OATP and BCRP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yafen Li role: CONTACT phone: 18222566785 email: liyafen314159@163.com name: Dongyang Liu role: PRINCIPAL_INVESTIGATOR name: Tianpei Hong role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06273202 id: 6257 briefTitle: Ultrasound Monitoring of Muscle Thickness in Premature Patients acronym: NeoMassage overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-07 date: 2025-01 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.
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The main questions it aims to answer are:
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* To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.
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* Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.
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Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.
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Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).
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Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present. conditions: Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Infant Massage measure: Quadriceps femuri thickness measure: Quadriceps femuri trophism measure: To valuate the discomfort/behavioral status of the infant. measure: To valuate the potential effects on spontaneous motility. measure: To evaluate differences in ponderal growth. sex: ALL minimumAge: 28 Weeks maximumAge: 35 Weeks stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06273189 id: 2017/558 briefTitle: Ultrasonic Bone Scalpel in BSSO overallStatus: COMPLETED date: 2018-12-15 date: 2020-12-15 date: 2021-12-15 date: 2024-02-22 date: 2024-02-22 name: TC Erciyes University class: OTHER briefSummary: The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Conventional name: Bone Scalpel measure: Cutting Time measure: neurosensory disturbance measure: The length of the procedure measure: The splitting time measure: The pattern of the split measure: postoperative edema sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selin Çelebi city: Kayseri state: Melikgazi zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06273176 id: MEC-2020-0812 briefTitle: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma acronym: RECMAP overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-22 date: 2024-02-22 name: Erasmus Medical Center class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.
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This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
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The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM). conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma conditions: Glioblastoma Multiforme of Brain conditions: Astrocytoma, Malignant conditions: Brain Neoplasms conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Neoplasms, Adult conditions: Recurrent Adult Brain Tumor conditions: Recurrent Glioblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Awake mapping under local anesthesia name: Asleep mapping under general anesthesia name: Resection under general anesthesia without mapping measure: Residual volume measure: Neurological morbidity at 6 weeks measure: Overall survival measure: Progression-free survival measure: Onco-functional outcome (OFO) measure: Serious Adverse Events measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Overall functioning at 6 weeks measure: Overall functioning at 3 months measure: Overall functioning at 6 months measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) sex: ALL maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: Universitätsklinikum Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, MD PhD role: CONTACT name: Sandro Krieg, MD PhD role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus Medical Center status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Jasper Gerritsen, MD PhD role: CONTACT lat: 51.9225 lon: 4.47917 facility: Haaglanden Medical Center status: RECRUITING city: The Hague country: Netherlands name: Marike Broekman, MD PhD role: CONTACT lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False
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<|newrecord|> nctId: NCT06273163 id: STU-2023-1168 briefTitle: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-31 date: 2024-12-31 date: 2024-02-22 date: 2024-03-08 name: University of Texas Southwestern Medical Center class: OTHER name: UT Southwestern Nutrition Obesity Research Center briefSummary: Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized repeated measures between-subjects design primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Medically tailored meals name: Noom® name: Usual care measure: Intervention Adherence measure: Intervention Satisfaction measure: Percent weight loss maintained measure: Diet quality measure: Incremental cost effective ratio (ICER) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Carolyn Haskins, MS role: CONTACT email: niche@utsouthwestern.edu name: Jessica Turcios, BS role: CONTACT email: niche@utsouthwestern.edu name: Kelseanna Hollis-Hansen, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06273150 id: 142048 briefTitle: Dentatorubral-pallidoluysian Atrophy Natural History and Biomarkers Study acronym: DRPLA NHBS overallStatus: RECRUITING date: 2022-05-01 date: 2026-04 date: 2026-04 date: 2024-02-22 date: 2024-02-22 name: University College, London class: OTHER name: University of North Carolina, Chapel Hill name: NYU Grossman School of Medicine briefSummary: DRPLA Natural History and Biomarkers Study (DRPLA NHBS) is a prospective observational study that will lay the foundation for clinical trials in DRPLA. The aims of this project are:
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* To characterize the natural history of DRPLA in both juvenile- and adult-onset patients and study different modalities of biomarkers in this condition.
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* To identify genetic factors and biomarkers that could predict disease progression.
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* To provide a platform to support the design and conduct of clinical trials.
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This study has three arms:
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1. Adult Participants: this arm of the study will require participants to be 16 years old or over to participate.
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2. Pediatric Participants: this arm of the study will require participants to be under 16 years old to participate.
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3. Remote Participants: patients that cannot or do not wish to travel to one of the study sites can participate in this arm of the study, irrespective of their age.
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Participants will have an annual visit for three years (baseline visit and two follow-up visits, three visits in total). Subjects who complete the whole protocol will be assessed on two consecutive days to reduce patient burden.
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This project will allow for a better understanding of DRPLA and its course, and therefore allow for future clinical trials on this condition to be more precisely and effectively conducted. conditions: Dentatorubral-Pallidoluysian Atrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Positive genetic test for pathological expansion in ATN1 measure: Scale for the assessment and rating of ataxia (SARA) measure: Brain atrophy measure: Neurofilament plasma concentration (NfL) measure: Inventory of non-ataxia signs (INAS) measure: Upper limb function test AIM-S measure: Redenlab DRPLA specific speech battery measure: Clinical Assessment of Dysphagia in Neurodegeneration (CADN) measure: Tau plasma concentration measure: Glial fibrillary acidic protein (GFAP) concentration measure: Ubiquitin carboxyterminal hydrolase L1 (UCH-L1) concentration sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Grossman School of Medicine status: RECRUITING city: New York state: New York zip: 10017 country: United States name: Claire Miller role: CONTACT phone: 212-263-4838 email: Claire.Miller@nyulangone.org lat: 40.71427 lon: -74.00597 facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599-7025 country: United States name: Yael Shiloh-Malawsky role: CONTACT phone: 919-966-2528 email: yaelm@neurology.unc.edu lat: 35.9132 lon: -79.05584 facility: University College London status: RECRUITING city: London zip: WC1N 3BG country: United Kingdom name: Paola Giunti role: CONTACT phone: +44 7899974923 email: p.giunti@ucl.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06273137 id: 2963 briefTitle: Positive Affect Treatment for Adolescents With Early Life Adversity acronym: PAT4ELA overallStatus: RECRUITING date: 2024-02-03 date: 2026-02-16 date: 2026-10-16 date: 2024-02-22 date: 2024-02-28 name: University of California, Irvine class: OTHER briefSummary: Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomized 1:1 to either receive PAT upon enrollment or after a waitlist period. primaryPurpose: PREVENTION masking: NONE count: 22 type: ESTIMATED name: Positive affect treatment measure: Positive affect measure: depressive symptoms - total measure: depressive symptoms - anhedonia subscale measure: Systemic inflammation - C-reactive protein (CRP) measure: Inflammatory gene expression sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: University of California Irvine status: RECRUITING city: Irvine state: California zip: 92617 country: United States name: Kate R Kuhlman role: CONTACT phone: 949-824-5574 email: krkuhl@uci.edu lat: 33.66946 lon: -117.82311 hasResults: False
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<|newrecord|> nctId: NCT06273124 id: 150-1261-00 briefTitle: Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes overallStatus: RECRUITING date: 2024-03-07 date: 2025-01-15 date: 2025-01-15 date: 2024-02-22 date: 2024-04-25 name: Tandem Diabetes Care, Inc. class: INDUSTRY name: Jaeb Center for Health Research briefSummary: The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).
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Participants will be asked to:
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1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
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2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods. primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: SteadiSet Extended Wear Infusion Set measure: Primary Outcome Measure measure: Primary Outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Memorial Hospital Presbyterian status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Brittany Dennis role: CONTACT phone: 949-764-6896 email: brittany.dennis@hoag.org name: David Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: Stanford University status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States name: Rayhan Lal role: CONTACT phone: 925-727-1317 email: inforay@stanford.edu name: Rayhan Lal, MD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 facility: Barbara Davis Center status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Samantha Lange role: CONTACT phone: 303-724-7514 email: samantha.lange@cuanschutz.edu name: Erin Cobry, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Endocrine Research Solutions status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States name: Jessica Tapia role: CONTACT phone: 678-878-4750 email: jtapia.ers@gmail.com name: John C Reed, MD role: PRINCIPAL_INVESTIGATOR lat: 34.02316 lon: -84.36159 facility: Rocky Mountain Clinical Research status: NOT_YET_RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Wyatt Larson role: CONTACT phone: 208-525-3736 email: Wyatt.larson@idahomed.com name: David Liljenquist, MD role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Northwestern University status: NOT_YET_RECRUITING city: Evanston state: Illinois zip: 60208 country: United States name: Grazia Aleppo role: CONTACT phone: 312-926-5431 email: aleppo@northwestern.edu name: Grazia Aleppo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.04114 lon: -87.69006 facility: Massachusetts General Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Amy Sabean role: CONTACT phone: 617-726-1729 email: asabean@mgh.harvard.edu name: Melissa Putman, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Henry Ford Health System status: NOT_YET_RECRUITING city: Detroit state: Michigan zip: 48202 country: United States name: Davida Kruger role: CONTACT phone: 313-916-3906 email: dkruger1@hfhs.org name: Davida Kruger, NP role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 facility: International Diabetes Center - HealthPartners Institute status: NOT_YET_RECRUITING city: Minneapolis state: Minnesota zip: 55416 country: United States name: Kathryn Leet, RD,LD, CDCES role: CONTACT phone: 952-993-9793 email: kathryn.leet@parknicollet.com name: Richard Bergenstal, MD role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Mayo Clinic status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Corey Kurek role: CONTACT phone: 507-255-0316 email: reid.corey@mayo.edu name: Yogish Kudva, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Icahn School of Medicine at Mt. Sinai status: NOT_YET_RECRUITING city: New York state: New York zip: 10029 country: United States name: Denisa Tamarez role: CONTACT phone: 212-241-9089 email: denisa.tamarez@mssm.edu name: Camilla Levister, MS, ANCP-C role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: SUNY Upstate Medical University status: RECRUITING city: Syracuse state: New York zip: 13210 country: United States name: Suzan Bzdick, RN, CDCES role: CONTACT phone: 315-464-9006 email: bzdicks@upstate.edu name: Ruth Weinstock, MD role: PRINCIPAL_INVESTIGATOR lat: 43.04812 lon: -76.14742 facility: Texas Diabetes and Endocrinology status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78731 country: United States name: Emmanuel Lopez role: CONTACT phone: 512-334-3505 email: elopez@texasdiabetes.com name: Jean Chen, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: Rainier Clinical Research Center status: NOT_YET_RECRUITING city: Renton state: Washington zip: 98057 country: United States name: Tina Mitchell role: CONTACT phone: 425-251-1720 email: TMitchell@rainier-research.com name: Frances Broyles, MD role: PRINCIPAL_INVESTIGATOR lat: 47.48288 lon: -122.21707 facility: University of Washington status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Dori Khakpour role: CONTACT phone: 206-945-4965 email: dorik@uw.edu name: Irl Hirsch, MD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06273111 id: 73840 briefTitle: Topical Simvastatin for Treating Infantile Hemangioma acronym: TSTIH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Joyce Teng class: OTHER name: Stanford University briefSummary: This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.
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The primary objective:
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To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.
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The secondary objective:
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1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).
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1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire. conditions: Hemangioma Skin studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: 5% simvastatin ointment measure: Number of Participants with Treatment-Related Adverse Events measure: Percentage of participants achieved a 50% HAS reduction at week 12 compared to baseline measure: Percentage of participants achieved a 75% HAS reduction from baseline by the end of the study (week 24) compared to baseline. measure: Percentage of targeted hemangiomas with complete or nearly complete resolution (IGA 0 or 1), defined as a minimal degree of telangiectasia, skin thickening, and no definitive palpable cutaneous texture changes. measure: Percentage of targeted hemangiomas that are stabilized (no noticeable change to baseline) or continue to progress. measure: Percentage of participants with a significant improvement in quality-of-life, defined as > 50% reduction in the IH-QoL questionnaire score from baseline to week 24. sex: ALL minimumAge: 3 Months maximumAge: 5 Years stdAges: CHILD facility: Stanford University city: Palo Alto state: California zip: 94304 country: United States name: Ramrada Lekwuttikarn, MD role: CONTACT phone: 650-313-8207 email: ramrada1@stanford.edu name: Thomas Buschbacher role: CONTACT phone: 352-278-7603 email: tbusch@stanford.edu lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06273098 id: 73162 briefTitle: School-Based Bladder Health Intervention overallStatus: WITHDRAWN date: 2028-01-01 date: 2033-12-31 date: 2033-12-31 date: 2024-02-22 date: 2024-04-24 name: Stanford University class: OTHER briefSummary: The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children. conditions: Urinary Dysfunction conditions: Lower Urinary Tract Symptoms conditions: Urinary Tract Infections conditions: Urinary Tract Infections in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 0 type: ACTUAL name: Bladder Health Education measure: Bathroom use measure: Symptom score measure: Urine volume sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Stanford Hospital and Clinics city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06273085 id: MOD00016877 briefTitle: Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction overallStatus: RECRUITING date: 2024-02-01 date: 2025-02 date: 2025-02 date: 2024-02-22 date: 2024-02-26 name: Medstar Health Baltimore class: OTHER briefSummary: The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital. conditions: Heart Failure conditions: Patient Acceptance of Health Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 500 type: ESTIMATED name: Patient education measure: Change in GDMT score measure: Heart Failure hospitalization measure: cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant measure: Number of GDMT classes of medications in use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medstar Union Memorial Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21218 country: United States name: Ahmad Amin, MD role: CONTACT phone: 401-533-0696 email: ahmad.amin@medstar.net lat: 39.29038 lon: -76.61219 facility: Medstar Harbor Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States name: Sumanth Bandaru, MBBS role: CONTACT phone: 646-240-5289 email: sumanthkumar.bandaru@medstar.net lat: 39.29038 lon: -76.61219 facility: Medstar Franklin Medical Center status: RECRUITING city: Baltimore state: Maryland zip: 21237 country: United States name: Anup Agarwal, MD role: CONTACT phone: 505-620-7815 email: anup.agarwal@medstar.net lat: 39.29038 lon: -76.61219 facility: Medstar Good Samaritan Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21239 country: United States name: Sumanth Bandaru, MBBS role: CONTACT phone: 646-240-5289 email: sumanthkumar.bandaru@medstar.net lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06273072 id: IRB00409080 id: R34HL166438-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R34HL166438-01A1 briefTitle: Metformin IN Asthma for Overweight and Obese Individuals (MINA) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-09-30 date: 2028-12-31 date: 2024-02-22 date: 2024-03-15 name: Johns Hopkins University class: OTHER name: Baylor College of Medicine name: National Heart, Lung, and Blood Institute (NHLBI) name: Temple University briefSummary: This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy. conditions: Asthma conditions: Asthma Chronic conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Metformin hydrochloride extended-release tablets name: Visually identical placebo Metformin hydrochloride extended-release tablets measure: Number of completed telemedicine visits measure: Adherence to study drug measure: Retention rate measure: Asthma control as assessed by the Asthma Control Test (ACT) score measure: Change in Asthma exacerbations rate measure: Pre-bronchodilator lung function measure: Fractional exhaled nitric oxide (FeNO) measure: Airways hyperresponsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273059 id: 22-07-0717 briefTitle: Genomic Study of Young-Onset Diabetes Mellitus overallStatus: RECRUITING date: 2022-09-12 date: 2024-12-12 date: 2024-12-12 date: 2024-02-22 date: 2024-02-22 name: Indonesia University class: OTHER briefSummary: Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population.
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Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes.
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However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients.
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This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications. conditions: Genomic conditions: Diabetes Mellitus conditions: MODY studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: The overall objective of this study is to identify and describe genetic variation of young-onset DM in Indonesia. measure: To describe the proportion of MODY in young-onset DM measure: To describe genetic variation of MODY in Indonesia. measure: To describe genetic variation in young-onset DM with diabetic complications in various systems: sex: ALL minimumAge: 8 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Cipto Mangunkusumo Hospital status: RECRUITING city: Jakarta Pusat state: DKI Jakarta zip: 10430 country: Indonesia role: CONTACT phone: 1 500 135 lat: -6.1818 lon: 106.8223 hasResults: False
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<|newrecord|> nctId: NCT06273046 id: PR(AG)614/2023 briefTitle: Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback overallStatus: RECRUITING date: 2024-04-19 date: 2025-04-28 date: 2025-12-31 date: 2024-02-22 date: 2024-04-25 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.
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Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.
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Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.
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Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.
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Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.
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Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.
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Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home. conditions: Fecal Incontinence conditions: Outlet Dysfunction Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Biofeedback name: Placebo measure: Fecal incontinence study: Number of anal leaks measure: Dyssinergic defecation study: Number of bowel movements measure: Incontinence study: Wexner scale measure: Incontinence study: Quality of life measure: Incontinence study: anxiety and depression measure: Incontinence study: Anal sphincter function measure: Dyssinergic defecation study: sensation of outlet obstructed evacuation measure: Dyssinergic defecation study: Wexner scale measure: Dyssinergic defecation study: Quality of life measure: Dyssinergic defecation study: anxiety and depression measure: Dyssinergic defecation study: defecatory maneuvers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Vall d'Hebron status: RECRUITING city: Barcelona country: Spain name: Jordi Serra, MD role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06273033 id: CONCORDE briefTitle: Implementation of Contemporary Coronary CT Angiography in Clinical Practice acronym: CONCORDE overallStatus: RECRUITING date: 2023-10-10 date: 2024-10 date: 2025-01 date: 2024-02-22 date: 2024-03-01 name: Humanitas Hospital, Italy class: OTHER briefSummary: Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe.
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The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies. conditions: Coronary Artery Disease of Significant Bypass Graft conditions: Coronary Syndrome conditions: Coronary Arteriosclerosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD. measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD. measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Carlo Andrea Pivato, MD role: CONTACT phone: +39 02 8224 7235 email: carlo.pivato@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False
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<|newrecord|> nctId: NCT06273020 id: MI22-00013 briefTitle: Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke overallStatus: RECRUITING date: 2022-11-17 date: 2024-11 date: 2024-12 date: 2024-02-22 date: 2024-02-22 name: Hospital Universitario Dr. Jose E. Gonzalez class: OTHER name: Ever Neuro Pharma GmbH briefSummary: A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes conditions: Ischemic Stroke, Acute conditions: Diabetes Mellitus, Type 2 conditions: Blood Brain Barrier studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are 3 groups in this clinical trial
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Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.
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Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
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Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Cerebrolysin name: Brain-MRI with contrast after 10-14 days of cerebrolysin measure: Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery measure: Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin measure: Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin measure: Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Servicio de Neurología del Hospital Universitario "Dr.José E. González" status: RECRUITING city: Nuevo León state: Monterrey zip: 64020 country: Mexico name: Servicio F de Neurología del Hospital Universitario "Dr.José E. González" role: CONTACT phone: +528183591111 email: neurologiahu.posgrado@gmail.com name: José C Becerra-Cruz, M.D. role: CONTACT phone: +522324393970 email: becerracruz@hotmail.com hasResults: False
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<|newrecord|> nctId: NCT06273007 id: EFP_2023_02_19 briefTitle: Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach acronym: PartoMa-Eth overallStatus: RECRUITING date: 2023-06-01 date: 2025-12-31 date: 2027-12-31 date: 2024-02-22 date: 2024-02-22 name: Haramaya Unversity class: OTHER name: University of Copenhagen name: Leiden University Medical Center name: Laerdal Foundation briefSummary: Overall Objective
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To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.
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Interventions
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1. Locally agreed and achievable intrapartum guidelines
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2. Low dose high frequency trainings (LDHF)
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